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Ibuprofen infants Drops 50 mg/1.25mL Suspension/ Drops — NDC 53943-637-09 (Billing 53943-0637-09)

by Discount Drug Mart, Inc · 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

This is a package of Ibuprofen infants Drops 50 mg/1.25mL Suspension/ Drops from Discount Drug Mart, Inc, no longer marketed (first marketed Feb 2025), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 53943-0637-09
🏷️ FDA NDC (as labeled) 53943-637-09 billing pads the product segment with a zero
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 53943-637-09 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
53943 labeler · 637 product · 09 package
Package marketed since
Feb 13, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5394363709 4
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Ibuprofen (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 2, 2026 — Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. (STRIDES PHARMA INC) · FDA recall D-0390-2026
Class III · Oct 29, 2024 — Failed Tablet/Capsule Specifications (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0047-2025
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0644-2024
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0646-2024
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0645-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Mar 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53943-637-09
Product NDC 53943-637
11-digit billing NDC 53943063709
RxCUI 204442
UNII WK2XYI10QM
Application # ANDA210755
SPL Set ID 2d582242-8b63-b51d-e063-6394a90a979a
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Mar 2025)
Marketing start 2025-02-13
Route ORAL
Dosage form SUSPENSION/ DROPS
Substance IBUPROFEN
Quick answers
  • RxCUI (RxNorm): 204442
Why two NDCs? The FDA registers this code as 53943-637-09 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 53943-0637-09. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other cardiac preparations, Antiinflammatory products for vaginal administration, Propionic acid derivatives
How it works Cyclooxygenase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a clas...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Over-the-counter ibuprofen helps with minor aches and pains like headache, toothache, backache, muscle aches, cramps and cold symptoms, and it lowers fever. Prescription versions a...
  • If ibuprofen upsets your stomach, take it with food or milk. Use the lowest dose that works for the shortest time you need.
  • The more common ones are nausea, vomiting, gas, headache and dizziness. These are usually manageable, but tell me if they bother you.
  • Stop and get help if you have black or bloody stools, vomit blood, chest pain, trouble breathing, weakness on one side, slurred speech, a skin rash, or swelling of the face. Also c...
📖 Read our full Ibuprofen guide →
1
Nutrient depletion considerations

Ibuprofen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Ibuprofen nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
53943-0637-09 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE 2025-02-13 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good neighbor pharmacy ibuprofen 50 mg/1.25mL 24385-0550-10 Amerisource 1 bottle $0.199 — Availability likely —
leader infants ibuprofen 50 mg/1.25mL 70000-0298-01 Cardinal 1 bottle $0.199 — Availability likely —
Foster and Thrive Ibuprofen 50 mg/1.25mL 70677-1146-01 Strategic 1 bottle $0.199 — Availability likely —
Concentrated ibuprofen infants 50 mg/1.25mL 83324-0005-30 Chain 1 bottle $0.201 — Availability likely —
Good Sense ibuprofen infants 50 mg/1.25mL 00113-0057-05 L. 1 bottle $0.325 — Availability likely —
ibuprofen 50 mg/1.25mL 00904-5463-35 Major 1 bottle $0.325 — Availability likely —
Foster and Thrive Infants Ibuprofen 50 mg/1.25mL 70677-1144-01 Strategic 1 bottle $0.325 — Availability likely —
Good Sense Infants Ibuprofen 50 mg/1.25mL 00113-0040-10 L. 1 bottle — — FDA listed —
Infants Ibuprofen 50 mg/1.25mL 00363-5100-01 Walgreens 1 bottle — — FDA listed —
infants ibuprofen 50 mg/1.25mL 00363-8139-10 Walgreen 1 bottle — — FDA listed —
Infants Advil 50 mg/1.25mL 00573-0191-20 Haleon 1 bottle — — FDA listed —
up and up dye free infants concentrated ibuprofen 50 mg/1.25mL 11673-0255-10 Target 1 bottle — — FDA listed —
ibuprofen 50 mg/1.25mL 11822-0255-01 Rite 1 bottle — — FDA listed —
signature care infants ibuprofen 50 mg/1.25mL 21130-0363-10 Safeway 1 bottle — — Discontinued —
Infants Ibuprofen 50 mg/1.25mL 21130-0513-10 Safeway 1 bottle — — FDA listed —
ibuprofen 50 mg/1.25mL 30142-0255-10 Kroger 1 bottle — — FDA listed —
infants dye free ibuprofen 50 mg/1.25mL 30142-0497-10 Kroger 1 bottle — — FDA listed —
Topcare Infants Ibuprofen 50 mg/1.25mL 36800-0057-05 Topco 1 bottle — — FDA listed —
Topcare Ibuprofen 50 mg/1.25mL 36800-0255-10 Topco 1 bottle — — FDA listed —
ibuprofen infants 50 mg/1.25mL 37808-0057-05 H 1 bottle — — FDA listed —
infants ibuprofen 50 mg/1.25mL 37808-0255-10 H 1 bottle — — FDA listed —
Equaline Ibuprofen 50 mg/1.25mL 41163-0057-05 United 1 bottle — — FDA listed —
equaline ibuprofen 50 mg/1.25mL 41163-0255-10 United 1 bottle — — FDA listed —
ibuprofen 50 mg/1.25mL 41250-0255-10 Meijer 1 bottle — — FDA listed —
care one ibuprofen 50 mg/1.25mL 41520-0255-10 American 1 bottle — — FDA listed —
ibuprofen infants 50 mg/1.25mL 42507-0057-05 HyVee 1 bottle — — FDA listed —
parents choice infants ibuprofen 50 mg/1.25mL 49035-0601-10 Wal-Mart 1 bottle — — FDA listed —
Concentrated ibuprofen infants 50 mg/1.25mL 49035-0635-09 Wal-Mart 1 bottle — — FDA listed —
Infants Motrin 50 mg/1.25mL 50580-0100-18 Kenvue 1 bottle — — FDA listed —
Motrin Infants 50 mg/1.25mL 50580-0198-50 Kenvue 1 bottle — — FDA listed —
IBUPROFEN Infants 50 mg/1.25mL 51672-2146-03 Sun 1 bottle — — FDA listed —
Concentrated ibuprofen infants 50 mg/1.25mL 53041-0637-09 Guardian 1 bottle — — FDA listed —
Ibuprofen infants Drops 50 mg/1.25mLthis 53943-0637-09 Discount 1 bottle — — Discontinued —
Infants Ibuprofen 50 mg/1.25mL 55319-0637-09 Family 1 bottle — — FDA listed —
dg health ibuprofen 50 mg/1.25mL 55910-0255-10 Dolgencorp, 1 bottle — — FDA listed —
Dg Health Ibuprofen 50 mg/1.25mL 55910-0503-05 Dolgencorp, 1 bottle — — FDA listed —
profen ib infants 50 mg/1.25mL 56062-0057-05 Publix 1 bottle — — FDA listed —
profen ib 50 mg/1.25mL 56062-0404-10 Publix 1 bottle — — FDA listed —
Infants Ibuprofen 50 mg/1.25mL 58602-0227-04 Aurohealth 1 bottle — — FDA listed —
ibuprofen 50 mg/1.25mL 59779-0313-05 CVS 1 bottle — — Discontinued —
Ibuprofen infants Drops 50 mg/1.25mL 69256-0687-09 Harris 1 bottle — — FDA listed —
basic care infants ibuprofen 50 mg/1.25mL 72288-0057-10 Amazon.com 1 bottle — — FDA listed —
basic care infants ibuprofen 50 mg/1.25mL 72288-0255-10 Amazon.com 1 bottle — — FDA listed —
Infants Ibuprofen 50 mg/1.25mL 72288-0770-10 Amazon.com 1 bottle — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Ibuprofen inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDiscount Drug Mart, Inc
Application holderGUARDIAN DRUG CO
FDA applicationANDA210755 (ANDA)
Labeler code53943
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio42 products on file

More NDCs from Discount Drug Mart, Inc labeler code 53943

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

USE(S) temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

⏱️ Dosage and Administration 104 words ▾

DIRECTIONS this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using find right dose on chart below. If possible, use weight to dose; otherwise use age. mL=milliliter measure with dosing device provided. Do not use any other dosing device. dispense liquid slowly into the child's mouth, toward the inner cheek if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart WEIGHT (lb) AGE (mos) DOSE (mL) under 6 mos ask a doctor 12-17 lbs 6-11 mos 1.25 mL 18-23 lbs 12-23 years 1.875 mL

⚠️ Warnings 182 words ▾

WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

📦 Storage and Handling 39 words ▾

OTHER INFORMATION store between 20-25 o C (68-77 o F) do not use if carton is opened or if printed neckband is imprinted with "SEALED FOR YOUR PROTECTION" and "USE WITH ENCLOSED DOSING DEVICE ONLY" is broken or missing.

🧪 Active Ingredient 13 words ▾

ACTIVE INGREDIENT (in each 1.25 mL) Ibuprofen 50 mg (NSAID)* *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 19 words ▾

INACTIVE INGREDIENTS anhydrous citric acid, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

🎯 Purpose 4 words ▾

PURPOSE Pain reliever/fever reducer

📄 Do Not Use 26 words ▾

DO NOT USE if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery

📄 Ask a Doctor Before Use If 78 words ▾

ASK A DOCTOR BEFORE USE IF stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, kidney disease or had a stroke child has asthma child is taking a diuretic

📄 Ask a Doctor or Pharmacist Before Use If 23 words ▾

ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS under a doctor's care for any serious condition taking any other drug

📄 When Using This Product 13 words ▾

WHEN USING THIS PRODUCT take with food or milk if stomach upset occurs

📄 Stop Use and Ask a Doctor If 96 words ▾

STOP USE AND ASK DOCTOR IF child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of the body slurred speech leg swelling the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear

📄 Keep Out of Reach of Children 22 words ▾

KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📄 Package Label / Principal Display Panel 68 words ▾

PRINCIPAL DISPLAY PANEL Compare to Concentrated Motrin ® Infants' Drops active ingredient* See New Warnings NDC 53943-637-09 Discount drug mart FOOD FAIR For Ages 6 mos. to 23 mos. Concentrated Infants' Drops IBUPROFEN Oral Suspension, 50 mg per 1.25 mL Pain Reliever /Fever Reducer ( NSAID ) Lasts Up to 8 Hours Dye-Free Use Only With Enclosed Syringe 1 fl oz (30 mL) Berry Flavor 637-01-ddm-x.jpg 637-01-ddm-o-.jpg 637-01-ddm-o.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ibuprofen (matched by generic name) — the program that covers self-administered drugs. 19 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ibuprofen. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$12.28M
Claims incl. refills
1.8M
Beneficiaries
1.4M
Spend / beneficiary
$8.95
Spend / claim
$6.72
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Discount Drug Mart, Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 53943-0614-05 · Discount 53943-0652-14 · DISCOUNT →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.